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Pre-Loaded CK Visicoil Gold Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The Pre-Loaded CK Visicoil a sterile device, in the form of two gold coils and a PGLA spacer loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm.

The Pre-Loaded CK Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method.

The Pre-Loaded CK Visicoil will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures.

Depending on the coil size (0.35mm, 0.50mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coils and spacer are supplied loaded and ready for use in the applicable needle.

The provided text describes the 510(k) submission for the RadioMed™ Pre-Loaded CK Visicoil Marker. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through comparison of technological characteristics and compliance with recognized standards.

Here's an attempt to answer the questions based on the provided text, indicating when information is not present:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. No specific acceptance criteria or quantitative performance metrics for the device itself are reported in this text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document does not describe a clinical performance study with a distinct test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As there's no described performance study or test set, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. No adjudication method is mentioned for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is a physical marker and not an AI or imaging system, so an MRMC study related to AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. The device is a physical marker; it does not involve algorithms or human-in-the-loop performance in the context of an AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. The document does not describe a study that would require establishing a ground truth for device performance in the sense of diagnostic accuracy or efficacy. The "ground truth" for this type of device would likely be its physical properties and functionality.

8. The sample size for the training set

This information is not provided. There is no mention of a training set as this is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

This information is not provided. No training set is mentioned.

Summary of available "Performance Testing" information:

The document mentions "Performance Testing" in Section 7, but it refers to compliance with general standards rather than specific device performance criteria:

• Standards Achieved:
  • ISO 10993: Biological Evaluation of Medical Devices (This indicates biocompatibility testing was performed, but specific results are not detailed).
  • FDA QSR 21 CFR Part 820: Good Manufacturing Practices (This indicates compliance with manufacturing processes and quality systems).

The submission relies on demonstrating that the new device (Pre-Loaded CK Visicoil Gold Marker) shares the "fundamental scientific technology" with and is "identical" in certain design aspects to its predicate devices:

• Visicoil™ Pre-Loaded Visicoil Marker (K070305)
• Brachy Needles/Sleeves/Spacers/Markers (K103449)

The key modification described is the configuration of loading two gold coils and a PGLA spacer into a needle, which is stated to be identical to one of the predicate products (K103449). The intended use is also stated as "has not changed."

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